Food Import Security Rules Expanded
Most food processors, importers have 12 months to comply with the new requirements
WASHINGTON, DC - 12/08/04 - The US Food & Drug Administration (FDA) has unveiled a new regulation requiring food producers and importers to create and maintain records indicating the immediate source and "immediate subsequent recipient" in the US of their products.
The final regulation is part of Washington's "efforts to protect the US food supply from intentional or accidental food adulteration" and is intended to help the FDA effectively trace and remove from the food supply any item that poses a "significant health threat," said Acting FDA Commissioner, Dr. Lester Crawford.
"These records," he said, "will be crucial for the FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists."
The new rule and Crawford's comments come on the heels of widely reported comments by Tommy Thompson, outgoing Secretary of Health & Human Services, whose agency oversees the FDA.
Thompson, who recently announced his resignation from the Bush Administration, told reporters at a press conference Monday that he was "still not comfortable" about the safety of the US food supply, despite the new regulations and an increase in federal inspections of food imports.
"We have a ways to go," Thompson said, adding the FDA "needs more money from Congress to hire food inspectors and to improve technology."
The inspection and regulatory program "has come a long way," he said. "But, I'm still not satisfied."
The FDA's Crawford, speaking at a separate press briefing on the new FDA rules, insisted, however, that the country's was "getting safer" every day.
"We have to continue to improve and be as close to fail- safe as we can be," he told the press at a briefing on the new FDA rules.
"The ability to trace back will enable us to get to the source of contamination," he said. "The records also enable the FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."
Asked about the chances of an attack on the food system, Crawford said, "the probability is very low indeed, based on historical data that we have," adding the FDA was "looking for every eventuality" that could threaten the US food supply.
One issue that will be addressed by the new regulations is mandatory compliance and enforcement, he said.
The Bioterrorism Act, Crawford said, allows FDA to seek criminal actions in federal court to prosecute persons who fail to establish and maintain the required records.
"This final rule includes complex new requirements for both record keeping and records access by FDA," commented Richard Jarman, vice president of the Washington, DC-based National Food Processors Association (NFPA).
"Understanding and interpreting these new requirements will be a top priority for the food industry," he said. "Internal industry communication and education "will be the key to ensuring the incorporation of these new requirements into daily operations."
The new regulation is the fourth rule-making adopted under the authority of the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" - the Bioterrorism Act - which directs the FDA to develop regulations designed to increase the safety and security of the US human food and animal feed supply.
The three previous final regulations in effect cover the registration foreign and domestic food facilities; the prior notice of food shipments imported or offered for import into the US; and so-called "administrative detention," so that food products that might pose a threat of serious adverse health consequences or death may be detained.
Under the newest requirement, manufacturers, food processors, packers, and importers must maintain records on food for human consumption for six months to two years, depending on the shelf life of the food, and records on animal feed for one year.
Companies that transport food products including ocean carriers, airlines, truck lines, and railroads are only required to retain records for one year regardless of the food or feed transported.
Most covered businesses have 12 months to comply with the rule, but small businesses - those with more than 10 but fewer than 500 employees - have 18 months to comply, while very small businesses which have 10 or fewer employees have 24 months to comply, according to the new rule.
The FDA - which is responsible for the quality of about 80% of the food products consumed in the US - also issued draft guidance detailing the procedures it will follow before requesting access to records.
Seven public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and answer questions, the agency said.
The text of all four rules is available at http://www.fda.gov/oc/bioterrorism/bioact.html
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